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A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)
A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

NCT07033494

RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Early Alzheimer's Disease

Interventions: MK-2214, Placebo

Countries: United States, Argentina, Australia, Belgium, Canada, Japan, Netherlands, Singapore

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD. The goals of the study are to learn: * If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment. * About the safety of MK-2214 and if people tolerate it

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
* Has a designated study partner who can fulfill the requirements of this study
* If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a known history of stroke or cerebrovascular disease
* Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
* Has structural brain disease
* Has a history of seizures or epilepsy within 5 years before screening
* Has any other major central nervous system trauma, or infections that affect brain function
* Has major medical illness or unstable medical condition within 3 months before screening
* Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
* Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
* Has a bleeding disorder that is not under adequate control
* Has a history of malignancy occurring within 5 years of screening
* Has a risk factor for corrected QT interval (QTc) prolongation
* Has liver disease
* Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
* Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision
Locations (79)
  • Irvine, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Redlands, California, United States
  • San Francisco, California, United States
  • Santa Ana, California, United States
  • New Haven, Connecticut, United States
  • Atlantis, Florida, United States
  • Fort Myers, Florida, United States
  • Maitland, Florida, United States
  • Melbourne, Florida, United States
  • Miami Lakes, Florida, United States
  • Naples, Florida, United States
  • New Port Richey, Florida, United States
  • Ocala, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • The Villages, Florida, United States
  • Winter Park, Florida, United States
  • Decatur, Georgia, United States
  • Elk Grove Village, Illinois, United States
  • Newton, Massachusetts, United States
  • Chesterfield, Missouri, United States
  • Ridgewood, New Jersey, United States
  • Springfield, New Jersey, United States
  • Toms River, New Jersey, United States
  • Albany, New York, United States
  • New Windsor, New York, United States
  • Queens, New York, United States
  • + 49 more on CT.gov